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medwireNews: In this roundup we report on three phase III trials, two investigating trastuzumab emtansine in HER2-positive breast cancer and one assessing tailored neoadjuvant therapy in soft tissue sarcoma, and also on an analysis of postmarketing safety events.
The final analyses of two phase III trials reported in The Lancet Oncology confirm the role of trastuzumab emtansine in the treatment of advanced HER2-positive breast cancer.
In EMILIA, median overall survival (OS) was 29.9 months for the 495 previously treated patients with locally advanced or metastatic disease who were randomly assigned to receive the antibody–drug conjugate and 25.9 months for their 496 counterparts given capecitabine plus lapatinib. This equated to a significant hazard ratio (HR) of 0.75, reports the team led by Véronique Diéras (Institut Curie Paris & Saint Cloud, France).
Similarly, Ian Krop (Dana-Farber Cancer Institute, Boston, Massachusetts, USA) and colleagues found that trastuzumab emtansine outperformed physicians’ choice of treatment among the 602 participants of the TH3RESA trial, all of whom had progressed on two or more HER2-directed therapies, with median OS times of 22.7 versus 15.8 months (HR=0.68).
In both trials, the survival benefit was observed despite a high rate of crossover from the control to the trastuzumab emtansine arm, with rates of 27% and 47% in the EMILIA and TH3RESA studies, respectively.
In patients with high-risk soft tissue sarcoma of the trunk and extremities, histotype-tailored neoadjuvant chemotherapy does not improve disease-free survival (DFS) or OS over standard chemotherapy with full-dose anthracycline plus ifosfamide, shows a futility analysis of a phase III trial published in The Lancet Oncology.
Indeed, Alessandro Gronchi (Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy) and study co-authors found that DFS and OS rates at 46 months were significantly lower with tailored than standard chemotherapy, at 38% versus 62% and 64% versus 89%, respectively, representing “new data in support of the efficacy of neoadjuvant standard chemotherapy.”
Researcher Joseph Ross (Yale University School of Medicine, New Haven, Connecticut, USA) and co-workers report in JAMA that postmarket safety events – specifically, withdrawals, boxed warnings, and safety communications – were reported for 32% of the 222 novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010.
These findings highlight “the importance of continuous monitoring of the safety of novel therapeutics throughout their life cycle,” say the study authors.
Such events were most common for agents indicated for psychiatric disease and least common for cancer and hematologic therapeutics, with rates of 60.0% and 21.4%, respectively.
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